TrialPerfect, is the back-end database from AMPS, and complements CalECG, our well-known AMPS on-screen measurement tool. We can combine CalECG with TrialPerfect to meet your clinical trial needs. With this powerful tool, you have the complete solution for ECG measurement and related applications.
How does this work? TrialPerfect and CalECG work in tandem to ensure a professional and safe client/server environment for:
- review of ECG traces
TrialPerfect supports all the file formats supported by CalECG (examples: Mortara E-Scribe XML, Muse transactional XML, and HL7 XML).
TrialPerfect offers user-friendly web-based interface. This means control of annotations becomes a back-end process.
TrialPerfect, complies with ’’21 CFR Part 11” having a complete Audit Trail capability. This database solution also allows setting up to five different user roles (Actors) critical for processing ECG traces during the entire Clinical Trial process. The Project Manager (PM) feature offers the user full customization of the study. The PM comes with the capability to grant the team members appropriate access and permissions consistent for their role and responsibilities in the study.
Quality Control is an important aspect of TrialPerfect. The tool enables users to automatically create HL7 XML FDA files at the end of the study. The user then submits these HL7 XML files to the FDA Warehouse using the AMPS FDA ECG Suite. So file validation occurs before their final physical submission.
Intra-reader and inter-reader variability can adversely affect the quality of the ECG measurements. TrialPerfect reduces this potential source of error by having a fully configurable intra-reader and inter-reader variability assessment.
AMPS have recently released TrialPerfect v3.0. This enhanced version offers the following new features and improvements:
- Increased safety for completed studies; it now requires two people to authorize the reopening of a study
- Affords Project Managers the ability to generate customized PDF report
- Interpretative statements are grouped in physiologic categories
- Keyboard selection of annotation caliper in CalECG
- Able to highlight abnormal annotation values in CalECG
- ECG number queue can be displayed in CalECG
- Able to annotate TpTe, QTP, JT, JTP and Pdur measurements
- Enhanced linkage to FAT-QT, with the possibility to use QRS, PR, JTp and JT intervals for classification
- Possibility to apply the FDA open-source algorithm ECGLib for the measurement of JTp/TpTe intervals